Stroke
Conditions
Brief summary
A four-weeks randomized clinical two-period crossover-design study will be conducted. Each patient will be randomized in a two separate consecutive treatment periods (Parallel Group Design). Group A will be treated with functional electrical stimulation (FES) and a second Gruppe B will be treated without FES for two weeks. After this period Group A and Group B will switched.
Detailed description
Prediction of motor recovery in the upper-limb (UL) / lower-limb (LL) in patients with stroke is generally based on clinical examination. However, according to former studies neurophysiological measures may also have a predictive value. In the acute phase, the combination of the motor score and SEPs are best predictive of outcome. Neurophysiological measures alone are of limited value in predicting long term outcome. However, predictive accuracy is substantially improved through the combined use of both of these measures and clinical variables. A four-weeks randomized clinical two-period crossover-design study will be conducted. Each patient will be randomized in a two separate consecutive treatment periods (Parallel Group Design). Group A will be treated with functional electrical stimulation (FES) and a second Gruppe B will be treated without FES for two weeks. After this period Group A and Group B will switched.
Interventions
DEVICEBioness-300
Therapeutic treatment of foot drop with the electrical stimulation device Bioness L300.
Sponsors
Peter Young Neurological Clinic Medicalpark Bad Feilnbach, Germany
LMU Klinikum
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
clinical sequential two-period crossover-design study
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adults between the ages of 18 and 75 * Inadequate ankle dorsiflexion during the swing phase of gait, resulting in inadequate limb clearance * Medically stable for at least one week following the last episode of stroke * Stable medication for four weeks * Adequate cognitive and communication function to give informed consent, understand the training instructions, use the device, and give adequate feedback * Ability to walk with or without an assistive device (except parallel bars) at least 10 meters
Exclusion criteria
* • Lower motor neuron injury with inadequate response to stimulation * History of falls greater than once a week * Severe cardiac disease such as myocardial infarction, congestive heart failure, or a demand pacemaker * Patients who have other electrical stimulation devices implemented * Patients with epilepsy and with autoimmune diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SEP measurement | 4 weeks | in improving pathological latencies and / or amplitudes of somatosensory evoked potentials (SEPs) • N35, P40, N50 (lower limb / tibial nerve) amplitude of somatosensory evoked potential \[ Time Frame: Change from baseline at 4 weeks\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Motor score improvement | 4 weeks | • Dorsal flexion/plantar extension of the ankle strength will be measured by Janda's classification of muscle imbalance patterns (Force produced by voluntary dorsiflexion). \[ Time Frame: Change from baseline at 4 weeks\] |
Countries
Germany
Outcome results
None listed